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The FDA Utilizes the Rosetta Syllego(TM) System to Support Management of Genome-Wide Association Study Data Submitted Through the VXDS Program

Rosetta Biosoftware Will Host a Webinar on the MAQC2 GWA Project, October
10, Featuring Federico Goodsaid, Ph.D., from the FDA.
SEATTLE, October 2 /CNW/ - Rosetta Biosoftware today announced that the
U.S. Food and Drug Administration (FDA) will utilize the Rosetta Syllego(TM)
system to meet its immediate need for a software solution to manage and
analyze genotyping data used in genome-wide association (GWA) studies.
Organizations are now beginning to submit genotyping data from GWA studies to
the FDA through its Voluntary eXploratory Data Submission (VXDS) program.
Research organizations conducting GWA studies have the potential to reveal
genetic risk factors for diseases such as coronary artery disease, type 2
diabetes and other complex diseases.
The use of genomic data is increasingly becoming an integral part of drug
and diagnostic development. The VXDS program provides an opportunity for
sponsors to submit genomic data for review by the FDA in a non-regulatory
context. VXDS submissions provide a means to ensure that reviewers at the FDA
are familiar with and prepared to appropriately evaluate future genomics
submissions, and for sponsors to understand the FDA regulatory process. To
streamline the evaluation of submissions and to develop a common understanding
of genomic data, the FDA also extended the Micro Array Quality Control (MAQC)
program to establish microarray quality control tools and guidelines for
genotyping data used in GWA studies.
"There are a growing number of genome-wide association study data
submissions to the FDA through VXDS," said Weida Tong, Ph.D., Director, Center
for Toxicoinformatics, National Center for Toxicological Research (NCTR)/FDA.
"A genotyping solution, such as the Syllego system, will benefit both the
industry and the FDA because it allows us to effectively manage genotyping
data submissions and also carry out analyses to understand why the sponsor
might have used a particular method to arrive at a specific outcome. We will
also explore the possibility of integrating the Syllego system with the
ArrayTrack software developed by the FDA."
The Syllego system is a genetic data management and analysis system that
includes tools for data management, quality control, data analysis, and
meta-analysis. The system provides a single repository for fast, easy access
to public and private data sets, reference annotation, and non-clinical and
clinical information.
In addition to the Rosetta Syllego system, another Rosetta Biosoftware
product, the Rosetta Resolver(R) system for gene expression data management
and analysis, is currently in place at the FDA's Center for Drug Evaluation
and Research (CDER). The FDA uses the Resolver system and other gene
expression tools alongside the FDA's genomic tool, ArrayTrack, to support the
VXDS program. The Resolver system was also adopted by the Critical Path
Institute, a non-profit research and education institution founded to help
implement the FDA's Critical Path Initiative.
"We are proud to extend our relationship with the FDA, and to provide the
FDA with powerful capabilities to manage and analyze genetic data," said
Yelena Shevelenko, vice president and general manager of Rosetta Biosoftware.
"By providing the Syllego system to the FDA for use with its VXDS initiative,
the FDA can focus its attention on understanding the outcome of a GWA study.
More importantly, by enabling the FDA with the technological capabilities of
the Syllego system, we will move the whole research community forward to
achieve the goals of personalized (translational) medicine."
Rosetta Biosoftware will present a Webinar featuring Federico Goodsaid,
Ph.D., and CDER/FDA on October 10, 2007. This Webinar will discuss the
FDA-initiated MAQC project focusing on genome-wide association studies. For
more information or to register for this Webinar, please visit
www.rosettabio.com/Webinars.
About the Rosetta Syllego System
The Rosetta Syllego system is Rosetta Biosoftware's practical solution
for genetic data management and analysis. The system is designed for
biologists, statistical geneticists, and investigators responsible for
generating genotyping data engaged in genetic studies, such as eQTL or
genome-wide association or linkage. The system captures and stores SNP
genotyping assay data and information from leading technology platforms for
better planning and execution of genetic studies. QC tools verify that data
are high quality to prevent loss of time in downstream analyses. Application
tools enable the combining of relevant genotypic and phenotypic study data and
the use of analysis methods of choice. Data management and visualization tools
enable the analysis and cataloging of study data and analysis results, for
incorporation into future studies. For more information on the Syllego system,
please visit http://www.rosettabio.com/syllego.
About Rosetta Biosoftware
Rosetta Biosoftware is a leading provider of informatics solutions for
life science research. Its comprehensive software solutions, including the
Rosetta Resolver, Rosetta Syllego and Rosetta Elucidator systems, empower life
scientists with advanced, scalable, and easy-to-use analysis platforms that
accelerate discovery research and enable personalized medicine. Rosetta
Biosoftware is a business unit of Rosetta Inpharmatics LLC, a wholly owned
subsidiary of Merck &amp; Co., Inc. (NYSE: MRK). More information about Rosetta
Biosoftware is available at www.rosettabio.com.
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements involve risks and uncertainties, which may cause results to differ
materially from those set forth in the statements. The forward-looking
statements may include statements regarding product development, product
potential, or financial performance. No forward-looking statement can be
guaranteed, and actual results may differ materially from those projected.
Neither Rosetta Inpharmatics nor Merck &amp; Co., Inc. undertakes any obligation
to publicly update any forward-looking statement, whether as a result of new
information, future events, or otherwise. Forward-looking statements in this
press release should be evaluated together with the many uncertainties that
affect the business of Merck &amp; Co., Inc. including, among others, the extent
to which Rosetta Inpharmatics' technology platform can be used in drug
discovery programs, uncertainty of market acceptance of Rosetta Inpharmatics'
technologies, ability to compete against existing technologies, and those
mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the
year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form
8-K (if any) which are incorporated by reference.
Rosetta Resolver and Elucidator are U.S. registered trademarks of Rosetta
Inpharmatics LLC. Rosetta Syllego is a trademark of Rosetta Inpharmatics LLC.